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Inhaled Corticosteroid Reduction and Elimination in Patients With Persistent Asthma Receiving Salmeterol
A Randomized Controlled Trial
Robert F. Lemanske, Jr, MD;
Christine A. Sorkness, PharmD;
Elizabeth A. Mauger, PhD;
Stephen C. Lazarus, MD;
Homer A. Boushey, MD;
John V. Fahy, MD;
Jeffrey M. Drazen, MD;
Vernon M. Chinchilli, PhD;
Timothy Craig, DO;
James E. Fish, MD;
Jean G. Ford, MD;
Elliot Israel, MD;
Monica Kraft, MD;
Richard J. Martin, MD;
Sami A. Nachman, MD;
Stephen P. Peters, MD, PhD;
Joseph D. Spahn, MD;
Stanley J. Szefler, MD;
for the Asthma Clinical Research Network of the National Heart, Lung, and Blood Institute
JAMA. 2001;285:2594-2603.
Context Inhaled long-acting  2-agonists improve asthma control when added to inhaled corticosteroid (ICS) therapy.
Objective To determine whether ICS therapy can be reduced or eliminated in patients with persistent asthma after adding a long-acting 2-agonist to their treatment regimen.
Design and Setting A 24-week randomized, controlled, blinded, double-dummy, parallel-group trial conducted at 6 National Institutes of Health–sponsored, university-based ambulatory care centers from February 1997 through January 1999.
Participants One hundred seventy-five patients aged 12 through 65 years with persistent asthma that was suboptimally controlled during a 6-week run-in period of treatment with inhaled triamcinolone acetonide (400 µg twice per day).
Intervention Patients continued triamcinolone therapy and were randomly assigned to receive add-on therapy with either placebo (placebo-minus group, n = 21) or salmeterol xinafoate, 42 µg twice per day (n = 154) for 2 weeks. The entire placebo-minus group was assigned and half of the salmeterol group (salmeterol-minus group) was randomly assigned to reduce by 50% (for 8 weeks) then eliminate (for 8 weeks) triamcinolone treatment. The other half of the salmeterol group (salmeterol-plus group) was randomly assigned to continue both salmeterol and triamcinolone for the remaining 16 weeks (active control group).
Main Outcome Measure Time to asthma treatment failure in patients receiving salmeterol.
Results Treatment failure occurred in 8.3% (95% confidence interval [CI], 2%-15%) of the salmeterol-minus group 8 weeks after triamcinolone treatment was reduced compared with 2.8% (95% CI, 0%-7%) of the salmeterol-plus group during the same period. Treatment failure occurred in 46.3% (95% CI, 34%-59%) of the salmeterol-minus group 8 weeks after triamcinolone therapy was eliminated compared with 13.7% (95% CI, 5%-22%) of the salmeterol-plus group. The relative risk (95% CI) of treatment failure at the end of the triamcinolone elimination phase in the salmeterol-minus group was 4.3 (2.0-9.2) compared with the salmeterol-plus group (P<.001).
Conclusions Our results indicate that in patients with persistent asthma suboptimally controlled by triamcinolone therapy alone but whose asthma symptoms improve after addition of salmeterol, a substantial reduction (50%) in triamcinolone dose can occur without a significant loss of asthma control. However, total elimination of triamcinolone therapy results in a significant deterioration in asthma control and, therefore, cannot be recommended.
Author Affiliations: Departments of Pediatrics, University of Wisconsin Medical School (Dr Lemanske) and Medicine, University of Wisconsin School of Pharmacy, Madison (Dr Sorkness); Health Evaluation Sciences (Drs Mauger and Chinchilli) and Medicine (Dr Craig), Milton S. Hershey Medical Center, Hershey, Pa; Medicine, University of California at San Francisco (Drs Lazarus, Boushey, and Fahy); Brigham and Women's Hospital and Harvard Medical School, Boston, Mass (Drs Drazen and Israel); Thomas Jefferson University, Philadelphia, Pa (Dr Fish and Peters); Harlem Hospital Center, New York, NY (Drs Ford and Nachman); Departments of Medicine (Drs Kraft and Martin) and Pediatrics (Drs Spahn and Szefler) National Jewish Medical and Research Center, Denver, Colo.
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